COMMUNITY HEALTH
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Health Alerts
RECALL ALERT
Nationwide recall of all strengths of Digitek (digoxin tablets, USP)
April 30, 2008
Actavis Totowa LLC notified healthcare professionals of a Class I nationwide recall of all strengths of Digitek, a drug used to treat heart failure and abnormal heart rhythms. The products are distributed by Mylan Pharmaceuticals Inc., under a “Bertek” label and by UDL Laboratories, Inc. under a “UDL” label. The product is being recalled due to the possibility that tablets with double the appropriate thickness may contain twice the approved level of active ingredient. The existence of double strength tablets poses a risk of digitalis toxicity in patents with renal failure. Digitalis toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability and bradycardia. Several reports of illnesses and injuries have been reported. Patients should contact their healthcare professional with questions. You can find more information on the Actavis Totowa website.
Measles outbreaks in the United States: Public health preparedness, control and response in healthcare settings and the community
April 2, 2008
A measles outbreak linked to an importation from Switzerland currently is ongoing in Arizona. The first case, with rash onset on February 12, 2008, occurred in an adult visitor from Switzerland who was hospitalized with measles and pneumonia. This hospital admission prompted verification of the measles immune status of approximately 1800 healthcare personnel and vaccination of those without evidence of immunity. Through March 31, 2008, nine confirmed cases have been reported to the Arizona Department of Health Services, and there are two suspected cases (one in a Colorado resident) and hundreds of contacts under investigation. The nine case-patients range in age from 10 months to 50 years. All but one were infected in healthcare settings, one of the five adult case-patients is a healthcare worker, and all cases were unvaccinated at the time of exposure.
Preventing transmission in healthcare settings
To prevent transmission of measles in healthcare settings, airborne infection control precautions (available at http://www.cdc.gov/ncidod/dhqp/gl_isolation.html should be followed stringently.
Further information on measles and measles vaccine is available at state health departments’ websites and at http://www.cdc.gov/vaccines/vpd-vac/measles/default.htm.
RECALL ALERT
PRICARA™ Recalls 25 mcg/hr Duragesic® (fentanyl transdermal system) CII Pain Patches
February 12, 2008
PriCara, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. said today that all lots of 25 microgram/hour (mcg/hr) DURAGESIC® (fentanyl transdermal system) CII patches sold by PriCara in the United States and all 25 mcg/hr fentanyl patches sold by Sandoz Inc. in the United States are being voluntarily recalled as a precaution from wholesalers and pharmacies. The recalled patches all have expiration dates on or before December 2009, and all are manufactured by ALZA Corporation, an affiliate of PriCara. The recall is being conducted in cooperation with the U.S. Food and Drug Administration. All 25 mcg/hr fentanyl patches manufactured by ALZA and sold in Canada also are being recalled.
DURAGESIC 25 mcg/hr (fentanyl transdermal system) and Sandoz Inc. 25 mcg/hr fentanyl transdermal system patches being recalled may have a cut along one side of the drug reservoir within the patch. The result is possible release of fentanyl gel from the gel reservoir into the pouch in which the patch is packaged, exposing patients or caregivers directly to fentanyl gel. As per the approved product labeling for DURAGESIC, fentanyl is a potent Schedule II opioid medication. Fentanyl patches that are cut or damaged in any way should not be used. Exposure to fentanyl gel may lead to serious adverse events, including respiratory depression and possible overdose, which may be fatal. Anyone who comes in contact with fentanyl gel should thoroughly rinse exposed skin with large amounts of water only; do not use soap. Immediately dispose of affected patches with cut edges by flushing them down the toilet, using caution not to handle them directly. Patches with a cut edge that have leaked gel will not provide effective pain relief.
Anyone who has 25 mcg/hr DURAGESIC or Sandoz Inc. fentanyl patches should check the box or foil pouch for the expiration date to see if they have patches that are being recalled. The recalled patches all have expiration dates on or before December 2009. The cut edge in affected patches can be seen upon opening the sealed foil pouch that holds the patch. Affected patches should not be handled directly.
Anyone with 25 mcg/hr DURAGESIC patches being recalled should call 800-547-6446.
Anyone with 25 mcg/hr Sandoz Inc. patches being recalled should call 800-901-7236.
Patients using fentanyl patches who have medical questions should contact their health-care providers.
For more information, visit http://www.duragesic/. com.
EXPANDED RECALL ALERT
Am2Pat, Sierra Pre-filled and B. Braun prefilled heparin and saline flush syringes
January 18, 2008
The Pennsylvania Department of Health (PADOH) is releasing the following information regarding the Expanded Recall Alert for Am2Pat, Sierra pre-filled and B. Braun prefilled heparin and saline flush syringes:
CDC has notified state health departments that Am2Pat intends to extend the recall of prefilled heparin and saline flush syringes to encompass all distributed lots of these products because of concerns these syringes may be contaminated with Serratia marcescens.
On December 20, 2007, Am2Pat recalled one lot of prefilled heparin flush syringes –(
http://www.fda.gov/oc/po/firmrecalls/am2pat12_07.html
)
CDC has been informed that the updated recall will now apply to ALL prefilled heparin and saline flush syringes made by Am2Pat.
These syringes were manufactured by Am2Pat and may be labeled as: Am2Pat, Sierra Pre-filled, or B. Braun. These products will all bear the National Drug Code or NDC prefix of: 64054.
They have been distributed to in-patient and out-patient facilities and directly to patients by home-care companies.
Patients and clinicians should immediately stop using these products. Persons who have questions regarding the manufacturer of prefilled syringes they are using should call the supply company that provided the syringes.
Healthcare practitioners identifying cases of Serratia bloodstream infections among patients who might have been exposed to these products should report these to their local health department.
Local health departments identifying cases of Serratia bloodstream infections potentially related to the recalled products are asked to report the information to their state health departments.
Chantix (Varenicline)
FDA Reviewing Post Marketing Cases Describing Suicidal Ideation An d Occasional Suicidal Behavior
November 20, 2007
FDA informed healthcare professionals of reports of suicidal thoughts and aggressive and erratic behavior in patient who have taken Chantix, a smoking cessation product. There are also reports of patients experiencing drowsiness that affected their ability to drive or operate machinery. FDA is currently reviewing these cases, along with other recent reports. A preliminary assessment reveals that many of the cases reflect new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment. The role of Chantix in these cases is not clear because smoking cessation, with or without treatment, is associated with nicotine withdrawal symptoms and has also been associated with the exacerbation of underlying psychiatric illness. However, not all patients described in the cases had preexisting psychiatric illness and not all had discontinued smoking.
Healthcare professionals should monitor patients taking Chantix for behavior and mood changes. Patients taking this product should report behavior or mood changes to their doctor and use caution when driving or operating machinery until they know how quitting smoking with Chantix may affect them.
Read the complete 2007 MedWatch safety summary including a link to the FDA Early Communication Sheet about an Ongoing Safety Review regarding this issue at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Chantix.
FDA Issues Safety Alert on Avandia
May 21, 2007
The U.S. Food and Drug Administration (FDA) is aware of a potential safety issue related to Avandia (rosiglitazone), a drug approved to treat type 2 diabetes. Safety data from controlled clinical trials have shown that there is a potentially significant increase in the risk of heart attack and heart-related deaths in patients taking Avandia. However, other published and unpublished data from long-term clinical trials of Avandia, including reanalyses of data from DREAM (a previously conducted placebo-controlled, randomized trial) provide contradictory evidence about the riskd in patients treated with Avandia.
Patients who are taking Avandia, especially those who are known to have underlying heart disease or who are at high risk of heart attack should talk to their doctor about this new information as they evaluate the available treatment options for their type 2 diabetes.
To see a list of Health Alerts in our archives, click here.
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